【摘要】 目的：本研究旨在利用FDA不良事件报告系统(FAERS)的数据，对罗氟司特片开展上市后安全性再评价，挖掘其真实世界用药风险，为临床安全用药提供参考。方法：提取2011—2025年FAERS数据库中罗氟司特片相关的不良事件(AEs)报告，综合应用报告比值比、比例报告比、贝叶斯置信传播神经网络及多项目γ泊松收缩器四种算法进行信号挖掘，同步开展亚组分析与起病时间分析。结果：共纳入罗氟司特片被确定为“主要疑似”的3 276份AEs报告，≥65岁男性AEs报告占比最高，大多数AEs发生在罗氟司特使用的前30 d内，AEs涉及26种器官系统，经四种方法共同筛选得到首选术语共63个。本研究识别出巴雷特食管、胃溃疡、胃十二指肠溃疡以及心律失常等多个药品说明书及现有文献未记载的新AEs信号。结论：本研究基于FAERS数据库开展罗氟司特片上市后安全性分析，所发现的说明书未记载的新不良反应值得关注，相关结论为其临床安全应用补充了重要风险依据。更多还原

【Abstract】 OBJECTIVE: To perform the post-marketing safety re-evaluation on Roflumilast tablets based on the U.S. Food and Drug Administration Adverse Event Reporting System(FAERS) database, to identify the actual risks associated with the use in the real world, and to provide reference for safe clinical medication. METHODS: Adverse events(AEs) reports related to Roflumilast tablets from the U.S. FAERS database(from 2011 to 2025) were extracted. Four algorithms such as report odds ratio, proportional report ratio, Bayesian belief propagation neural network and multi-item Gamma Poisson constrictor were used for signal mining. Subgroup analysis and time-to-onset analysis were performed concurrently. RESULTS: A total of 3,276 AEs reports for Roflumilast tablets were included, with the highest proportion of AEs reports in men ≥65 years of age. Most AEs occurred within the first 30 d of Roflumilast tablets admonistration. These events involved 26 system organ classes and yielded 63 potential targets identified through four screening methods. This study identified several new AEs signals, including Barrett’s esophagus, gastric ulcers, gastroduodenal ulcers, and arrhythmias, which were not documented in drug instructions or existing literature. CONCLUSIONS: This study represents the first post-marketing safety analysis of Roflumilast tablets based on the U.S. FAERS database. The new adverse drug reactions not recorded in the drug instructions are worthy of attention, and the relevant conclusions provide important risk basis for its clinical safe application.更多还原